Europe approves Gilead's HIV combo Eviplera

The European Commission has granted marketing authorisation for Gilead Sciences' combination drug Eviplera, for HIV-1 infection.

Eviplera is a once-daily single-tablet that combines Gilead's Truvada (tenofovir/emtricitabine) and Johnson & Johnson and Tibotec's Edurant (rilpivirine). The approval was supported by 48-week data from two Phase III studies conducted by J&J unit Tibotec.

Gilead quoted Mark Nelson of the Chelsea and Westminster Hospital in London as saying that with people with HIV living and remaining on treatment longer, "the availability of new simplified therapeutic options has become even more critical”. He added that “Eviplera has the potential to be an important new treatment option for patients starting HIV therapy because it streamlines an effective HIV treatment regimen into a single daily tablet.”

The regimen received approval from the US Food and Drug Administration under the tradename Complera in August 2011. Eviplera is the second single-tablet HIV regimen to be authorised in Europe after Atripla, which combines Gilead's Emtriva (emtricitabine) and Viread (tenofovir) with Bristol-Myers Squibb’s Sustiva (efavirenz) and is sold through a three-way joint venture set up with Merck & Co.